Prospective ED Headache Cohort Study
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|ClinicalTrials.gov Identifier: NCT00313703|
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : May 9, 2011
Last Update Posted : May 15, 2018
|Condition or disease|
The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.
The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.
After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.
|Study Type :||Observational|
|Actual Enrollment :||477 participants|
|Official Title:||Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache|
|Actual Study Start Date :||March 2004|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||November 2005|
- Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge [ Time Frame: 24 hours after Emergency Department (ED) discharge ]Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain
- Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal [ Time Frame: 3 months ]Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313703
|United States, New York|
|Montefiore Medical Center, 111 East 210th Street|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Benjamin Friedman, MD, MS||Department of Emergency Medicine, Montefiore Medical Center|